Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.

GUEST COLUMNISTS

Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

Implementing Medium And High-Volume Drug Handling And Packaging Programs
Simplify the complexity of combination product development by partnering for integrated support across device design, industrialization, manufacturing, and final product assembly.

Accelerating ADC Analytical Method Development Through Platform Innovation
Leverage a platform-based analytical development strategy to accelerate ADC IND readiness through early CQA identification, reduced development risk, and streamlined progression from development to patients.
How To Effectively Manage Local Affiliate Pharmacovigilance Outsourcing
Managing PV across dozens of markets strains even experienced safety teams. Learn about a framework that helps you maintain compliance, reduce risk, and scale confidently into new markets.
Is Mannitol Hemihydrate Detrimental To Protein Stability?
Maintaining an amorphous excipient matrix is crucial for protein stability. Learn about the importance of storage conditions in managing mannitol hemihydrate dehydration and ensuring protein stability.
Smart Scaling For Cell And Gene Therapies
To meet patient demand, advanced therapy manufacturing processes must be commercial ready. CGT sponsors can mitigate risk and protect viability by partnering with a CDMO that prioritizes scalability.
FDA's Regenerative Medicine Advanced Therapy (RMAT) Program
RMAT qualification requires preliminary clinical evidence demonstrating the potential to address an unmet medical need. This designation grants benefits like intensive guidance and faster FDA review.